Intact Vascular’s Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) Clinical Trial Commences Enrollment with First Implant of the Tack Endovascular System®

The TOBA II BTK clinical trial studies the combination of Intact Vascular’s Tack Endovascular System and standard balloon angioplasty in the treatment of patients with Critical Limb Ischemia (CLI)

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial has commenced enrollment, with the first patient treated by Dr. Joseph Cardenas at Yuma Regional Hospital and the Heart, Lung and Vascular Center in Yuma, Arizona.

The TOBA II BTK study is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI). The Tack Endovascular System is a new technology designed to repair dissections (or tears) in the artery wall that frequently occur as a complication of balloon angioplasty. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options. TOBA II BTK is the first known industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.

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